Evidence-aware assessment
Use program documents and structured context to identify what is present, what remains unclear, and what appears absent.
Global Gap Assessment
Find the gaps that could slow a submission—while there is still time to act.
Evaluate program evidence against the intended pathway and authority context, separate critical issues from lower-priority work, and turn the findings into a sequenced readiness plan.
Gulfstream Intelligence
Built for regulated work
- Assess quality, nonclinical, clinical, administrative, and program-specific readiness in one connected workspace.
- Trace findings back to the documents, assumptions, and regulatory context used in the assessment.
- Separate critical, major, and lower-priority gaps instead of producing an undifferentiated checklist.
- Carry prioritized actions into planning, reporting, authority preparation, and Slide Studio.
Human review
Private data
Traceable work
What it does
Purpose-built capability, connected to the rest of the program
Authority and pathway context
Frame readiness against the selected authority, submission type, development stage, and intended regulatory objective.
Severity and impact
Distinguish issues that may affect safety, reviewability, clinical progression, or filing readiness from routine follow-up work.
Prioritized remediation
Translate findings into clear next steps, dependencies, accountable owners, and realistic sequencing.
Decision-ready readiness view
Summarize readiness by domain so teams and executives can see where attention is needed without losing the underlying detail.
Connected follow-through
Use the same findings in submission planning, authority simulation, reporting, regulatory chat, and presentations.
Connected workflow
From source material to a usable regulatory output
- 01
Define the assessment basis
Choose the program, authority, pathway, development stage, and decision the assessment must support.
- 02
Connect the evidence
Bring in the relevant documents, prior decisions, assumptions, and source material.
- 03
Review and challenge findings
Evaluate gap statements, severity, rationale, evidence references, and uncertainty.
- 04
Move into execution
Convert confirmed gaps into an accountable remediation and submission-readiness plan.
Designed for decisions
Keep the context that generic tools lose
Gulfstream connects source material, regulatory reasoning, planning, and deliverables so teams do not have to reconstruct the same work in disconnected systems.
- Make readiness discussions specific rather than subjective.
- Focus limited resources on the issues most likely to matter.
- Preserve the evidence and rationale behind each finding.
- Expose missing assumptions before they become schedule surprises.
- Connect gap closure to submission milestones and decisions.
- Create executive views without flattening the regulatory detail.
Questions regulatory teams ask
What is regulatory gap assessment software?
It is a structured system for comparing the current evidence, documents, decisions, and program state against the requirements and expectations relevant to a regulatory objective. Useful software should preserve sources, rationale, uncertainty, severity, and recommended follow-through—not just generate a checklist.
Can Gulfstream perform an IND readiness assessment?
Gulfstream can support an IND readiness workflow across administrative, CMC, nonclinical, clinical, and program-planning domains. The assessment must be configured for the specific product and reviewed by qualified personnel against current FDA requirements and guidance.
Does it replace a regulatory professional?
No. Gulfstream is decision-support software. Qualified personnel remain responsible for selecting the assessment basis, confirming the evidence, challenging findings, interpreting authority expectations, and approving actions.
Can the assessment use private company documents?
Yes. Program Mode is designed to work with approved project documents and designated regulatory sources. Customer content remains subject to Gulfstream’s privacy, access-control, and data-handling practices.
How are findings carried into a submission plan?
Confirmed findings can inform tasks, dependencies, owners, target dates, reporting, and decision checkpoints in the connected Submission Planner instead of being left in a static assessment report.
Which authorities can be considered?
Gulfstream supports global regulatory work, including FDA, EMA, MHRA, Health Canada, PMDA, TGA, NMPA, and other authorities. The exact assessment basis should reflect the product, region, pathway, and current source set selected by the user.
Continue exploring
Connected Gulfstream capabilities
IND gap-assessment checklist
Review the domains and questions that should be resolved before an initial IND.
Learn moreSubmission Planner
Convert confirmed readiness gaps into sequenced, accountable work.
Learn moreSlide Studio
Communicate assessment findings in an editable, company-branded presentation.
Learn moreMove regulatory work forward